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FDA Left Out of Zika Emergency Funds

Oct. 7— The FDA is aiding the fight against the Zika virus without any dedicated Zika funding
in the new fiscal year.

The recently approved
$1.1 billion package of federal funding to respond to the Zika outbreak is expected
to generate more tests and vaccine candidates. However, that funding doesn't cover
the
Food and Drug Administration's costs in reviewing new policies and diagnostics and vaccines.

The agency already has spent millions of dollars on Zika work, an agency spokeswoman
told Bloomberg BNA. In addition, an advocate of more FDA funding said there already
is a “surge of work” on Zika at the agency.

Congress provided $1.1 billion at the end of September to respond to the outbreak
of the Zika virus as part of the
continuing resolution (H.R. 5325) to keep the government running through early December. That funding,
which came after months of fighting among Congress over provisions attached that funding,
allows the National Institutes of Health to continue its pursuit of a Zika vaccine,
and helps the Centers for Disease Control and Prevention with its public health response
(10 LSLR 20, 10/15/16).

400 People, $5 Million

As of late September, the FDA has spent $5 million in annual resources and “utilized”
more than 400 staff members to respond to the Zika virus, according to estimates provided
to Bloomberg BNA by the FDA.

“Because additional funding to support Zika virus response activities was not provided
to the FDA under H.R. 5325, the FDA will continue to leverage funding from its base
resources to sustain response activities,” FDA spokeswoman Tara Goodin said in an
Oct. 6 e-mail. “Sustaining scaled-up Zika response activities using current base resources
is a challenge and requires the FDA to reprioritize work in other important areas,
as well as limiting the FDA’s ability to support highly targeted regulatory science
research that is required for the efficient development and regulatory review of medical
products for Zika virus disease.”

The FDA describes regulatory science as the science of developing new tools, standards,
and approaches “to assess the safety, efficacy, quality, and performance of all FDA-regulated
products.”

Goodin said the FDA also has advanced the development of investigational vaccines
and therapeutics for Zika virus; reviewed the use of innovative strategies to help
suppress the population of virus-carrying mosquitoes that fall under FDA’s regulatory
authorities; and protected consumers from fraudulent products related to Zika virus.

“The FDA continues to work with the Congress to secure funding in the final FY 2017
funding bill,” she said in her e-mail.

A House appropriations panel had proposed a
$10 million boost for the FDA in fiscal year 2017 to respond to Zika and another crisis, Ebola, according
to Steven Grossman, deputy executive director of
Alliance for a Stronger FDA. But it wasn't part of any final funding deal.

“The pressure in the Zika area is already very much on FDA,” Grossman said in an Oct.
7 interview with Bloomberg BNA. Referring to the agency's emergency use approval of
diagnostic tests, he said, “So while it doesn’t quite classify as front-line work,
it is in effect the work that the front line needs.”

Grossman, whose group advocates for more congressional funding for the FDA and includes
regulated industries, acknowledged that a “good deal”
of the FDA's role in participating in the nation's Zika response probably will come
later, but he said there already is a “surge of work”
at the agency.

To contact the reporter on this story: Jeannie Baumann in Washington at
jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at
rkubetin@bna.com

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